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Active, not recruitingNCT06933602Updated Aug 24, 2025

Progressive Relaxation for COPD: Effects on Insomnia and Satisfaction

An interventional study of relaxin in COPD and Insomnia, sponsored by Ceylan Aksoy. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Ceylan Aksoy · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

In the life model based on the activities of living developed by nursing theorists Roper, Logan, and Tierney, sleep is identified as one of the twelve essential activities. Sleep is a fundamental need initiated by the circadian rhythm and sleep/wake homeostatic pressure, and it is followed by a period of wakefulness. Therefore, early identification of sleep disorders and the improvement of sleep and quality of life should be primary goals. As sleep quality improves, individuals feel better both physically and mentally; however, in individuals with Chronic Obstructive Pulmonary Disease (COPD), sleep problems tend to increase as symptoms worsen.

Non-pharmacological methods such as breathing exercises, reflexology, relaxation exercises, and physical exercises are commonly used to cope with symptoms in individuals with COPD. Among these, progressive muscle relaxation exercises (PMRE) have recently become an important component in the care of individuals with chronic illnesses, due to their benefits in reducing anxiety and stress, diverting attention from pain, and alleviating muscle tension and contractions.

Patient education, which is a component of the nurse's role as an educator, aims to help the patient prevent complications, gain self-sufficiency in daily life, cope with illnesses, adapt to the disease, and improve decision-making abilities. In addition to these numerous benefits, patient education also contributes to increased patient satisfaction. Progressive muscle relaxation training, by increasing body awareness-such as recognizing which muscles are located in which areas and how they react under stress-is considered an important educational tool that can enhance the patient's adaptation to the illness and assist in coping with symptoms.

The study will be conducted as a randomized controlled trial with a pretest-posttest experimental design. The sample will consist of a total of 70 patients-35 in the experimental group and 35 in the control group-who have been diagnosed with COPD at the Department of Chest Diseases in Van Yüzüncü Yıl University Dursun Odabaş Medical Center, meet the research criteria, and agree to participate in the study.

To ensure randomization, a dice-rolling method will be used. Each patient meeting the inclusion criteria will roll a die: if an odd number appears on the upper face, the patient will be assigned to the control group; if an even number, to the experimental group.

Both the experimental and control groups will be administered the Patient Information Form and the Insomnia Severity Index for Hospitalized Patients as pretests. In addition, the Patient Satisfaction with Education Scale will be applied as a posttest only to the experimental group.

While patients in the experimental group will be provided with an educational booklet and receive progressive muscle relaxation training, patients in the control group will receive routine nursing care and standard treatment without any additional training.

One week later, both groups will again be administered the Patient Information Form and the Insomnia Severity Index for Hospitalized Patients as posttests.

Data obtained from the study will be analyzed using the SPSS (Statistical Package for the Social Sciences) version 23.0 software.

02

Conditions studied

03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

This is the only study on the registry with Ceylan Aksoy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • being diagnosed with chronic obstructive pulmonary disease (COPD)

Exclusion criteria

Exclusion Criteria:

  • participants must not be under 18 years of age.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Implementation of Progressive Muscle Relaxation Training

    Other: relaxin

  • No intervention
    Control Group

Interventions

  • Otherrelaxin

    Progressive Muscle Relaxation (PMR) exercises help alleviate symptoms in patients with COPD by reducing the effects of anxiety and stress, distracting attention from pain, and relieving muscle tension and spasms. These exercises are beneficial in managing: Tension headaches Back pain Tension and pain in jaw muscles Tension and pain around the eye muscles Muscle spasms Insomnia Stress-related muscle tension The required content of the exercises for relieving stress-related tension will be provided in a booklet. The booklet will be given to the patients following the training session.

06

What researchers measure

Primary outcomes

  1. Hospital-Related Insomnia Scale:

    The Hospital-Related Insomnia Scale was developed by Çiftçi, Yıldız, and Yıldız (2023) to assess patients' levels of insomnia caused by hospital-related factors. The scale consists of 18 items and five subdimensions: physical environmental factors (items 1-5), psychological factors (items 6-9), safety factors (items 10-12), socio-economic factors (items 13-15), and nutritional factors (items 16-18). The Cronbach's alpha reliability coefficients for the subdimensions were 0.842, 0.804, 0.786, 0.677, and 0.672 respectively, while the overall internal consistency of the scale was found to be 0.783. The scale is evaluated by calculating the average score of the items, with scores ranging from 1 to 5. Higher scores indicate greater levels of hospital-related insomnia associated with the corresponding factor.

    Time frame: 7 day

07

Study locations

1 site
  • Ağrı İbrahim Çeçen University
    Ağrı, Ağrı 04100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06933602
Lead sponsor
Ceylan Aksoy
Responsible party
Ceylan Aksoy (LECTURER, Ataturk University) — Sponsor-investigator
First posted
Apr 18, 2025
Start date
Feb 1, 2025
Primary completion
Aug 22, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Aug 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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